Are Medical Device Recalls Preventable?

medical device recallsAccording to experts, the opinion as to whether medical device recalls are preventable differs greatly depending on the source. While some believe that eliminating recalls is not possible due to the inability to produce perfect devices, others feel that recalls are, in fact, preventable as long as consumers and manufacturers are careful enough.

Do you or a loved one have questions about medical device recalls? Are you considering filing a claim following a recall yet you are not sure whether you have a valid case? Contact an experienced attorney today who will review your situation and determine if you are eligible to seek compensation for your injuries.

Are Medical Device Recalls Preventable?

One member of an advisory panel for CDRH of the U.S. Food and Drug Administration (FDA) stated that devices will fail, unanticipated external forces will cause device concerns or problems and users may find new ways of using devices for which the products were never intended. Even without the complications of inferior parts, unanticipated problems will almost always arise and recalls are not necessarily preventable.

Additionally, since problems resulting in medical device recalls cannot be completely eliminated, according to one expert, attention may to turn to education of a diverse target audience. Not only must the patients understand the devices, but the distributors, sales forces, physicians and hospitals should also be experienced with the products. For instance, patients have a responsibility to notify the manufacturer and their physicians if they experience complications. Similarly, manufacturers must notify both the public and healthcare communities of potential complications and act quickly on the issues.

Manufacturers are constantly pushing the limits of technology, according to some experts, and sometimes the models used in the past have been proven to no longer be valid compared to previous products. Company culture may play a large role in minimizing both the scope and number of recalls. Unfortunately, while some companies may frown upon an employee speaking up or avoid acting on information when it becomes available, these businesses often face even greater repercussions when the truth becomes apparent; appearing to or being accused of putting profits or business needs ahead of consumer safety is rarely viewed as acceptable.

Some experts believe that eliminating all recalls is not possible and that agencies should either delete all regulation or manufacturers should produce perfect devices. Many consumers may not be in favor of the former, and companies may not be able to comply with the latter as long as products are designed and built by flawed humans. In other words, there is no such thing is a perfect process.

Additionally, some maintain that recalls are not all related to safety. A product may be recalled if it does not function in the manner in which the manufacturer attended. It may be recalled due to a typo in a user’s manual. It may be recalled due to a lockup or a sticky button. These instances pose no real danger to the operator or patient but often result in recalls.

On the other hand, many feel that a recall is preventable just as an accident can be avoided as long as all parties are careful. In reality, patients, physicians and human beings in general are often busy and rarely have time to go look up a question in a safety training manual. Some reportedly assert that manufacturers allow imperfect products to leave their facilities so that they can accomplish a goal within a certain time frame.

Questions about Medical Device Recalls or Lawsuits? Give Us a Call!

If you have questions about existing medical device recalls or concerns about filing your own lawsuit, contact Attorney Group today. We can address your concerns or possible claim for free and help to determine if you have an eligible case. Should we feel that you have a valid medical device lawsuit or are eligible to pursue a claim following a recall, we will connect you with an experienced attorney who will further assist you.